Browse Device Recalls
5,540 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,540 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 5,540 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes ... | Six (6) identified software issues which may result in the following: system keeps restarting, AM... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCO... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEU... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAK... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, ... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY,... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL L... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PA... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PO... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, K... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PA... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 11, 2025 | Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Ca... | Customers may experience inaccurate test results by observing a higher frequency of classificatio... | Class II | Fujirebio Diagnostics, Inc. |
| Dec 11, 2025 | Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges ... | Customers may experience inaccurate test results by observing a higher frequency of classificatio... | Class II | Fujirebio Diagnostics, Inc. |
| Dec 8, 2025 | Philips Azurion Systems R3.0. Includes the following label descriptions and c... | Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 4, 2025 | Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (C... | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Class II | Mobius Imaging, LLC |
| Dec 4, 2025 | Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (C... | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Class II | Mobius Imaging, LLC |
| Nov 29, 2025 | BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Fem... | Labeling error, Incorrect expiration date | Class II | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. |
| Nov 27, 2025 | Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Pr... | Behind-the-ear sound processer packaging label is different then included product. | Class II | Advanced Bionics, LLC |
| Nov 26, 2025 | MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E;... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR1... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E;... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 24, 2025 | BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. | Removal of affected lot of screws due to labeling error. | Class II | Smith & Nephew, Inc. |
| Nov 13, 2025 | KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus der... | Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. | Class II | Microbiologics Inc |
| Nov 12, 2025 | ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Co... | Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-l... | Class II | Cardinal Health 200, LLC |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety ... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tr... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tr... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety ... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tr... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 7, 2025 | Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tr... | IFU and device kit labeling contains misleading statements leading to improper securing of the de... | Class II | Rocket Medical Plc |
| Nov 6, 2025 | BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit R... | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | Class II | C.R. Bard Inc |
| Nov 6, 2025 | BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit ... | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | Class II | C.R. Bard Inc |
| Nov 6, 2025 | Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | Class II | C.R. Bard Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.